To evaluate the efficacy and safety of Botulinum Toxin Type A PUrified Neurotoxin Complex (BOTOX) compared to placebo for the treatment of upper limb essential tremor.
ELATE
(ELATE) Essential Tremor: A Phase 2 Multicenter, Randomized, Doduble-blind, Placebo-controlled Study of BOTOX for the Treatment of Upper Limb Essential Tremor
Tremor
All genders
18-80
Recruiting now
Overview
Principal Investigator: Dr. Bryan Ho
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Neuro Research
Study details
Inclusion Criteria
- Adults male or female, 18-80 years of age
- Has diagnosis of essential tremor in accordance with modified TRIG criteria
- First onset of essential tremor at least 1 year before Screening with stability of the tremor symptoms over 4 weeks previous to Screening
Exclusion Criteria
- Must not have any uncontrolled clinically significant medical condition other than the one under study
- Must not have any medical condition that may put the patient at increased risk with exposure to BOTOX (Ex. muscular dystrophy, myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, mitochondria disease, or any other significant disease that might interfere with neuromuscular function.
- Must not have exposure to the following tremorgenic drugs: lithium, valproic acid, amiodarone, typical and atypical neuroleptics within two weeks of Screening
Study Requirements
Set goals with the investigator. After completing screening phase, the participant will be randomized and complete study visits every three weeks for thirty-six weeks. During the screening phase, blood will be collected, patients will complete questionnaires, and a tremor assessments will be done. After randomization, patients will complete questionnaires and tremor assessments. BOTOX/placebo will be administered at randomization, week 12, and week 24.